Ignite Creation Date:
2025-12-24 @ 12:21 PM
Ignite Modification Date:
2026-03-08 @ 1:58 AM
Study NCT ID:
NCT02789761
Status:
UNKNOWN
Last Update Posted:
2016-06-03
First Post:
2016-04-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Vascular and Cognitive Effects of Chronic High-flavanol Intake in Healthy Males
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-05-27', 'studyFirstSubmitDate': '2016-04-25', 'studyFirstSubmitQcDate': '2016-05-27', 'lastUpdatePostDateStruct': {'date': '2016-06-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Flow-mediated Dilation (FMD)', 'timeFrame': 'Change from baseline at 14 days', 'description': 'Ultrasound-based assessment of brachial artery reactivity following induced reactive hyperemia'}], 'secondaryOutcomes': [{'measure': 'Blood pressure (BP)', 'timeFrame': 'Change from baseline at 14 days', 'description': 'Acute assessment of systolic and diastolic BP (3 repeats)'}, {'measure': 'Executive Function', 'timeFrame': 'Change from baseline at 14 days', 'description': 'Assessed by cognitive test battery'}, {'measure': 'Endothelial progenitor cells and Microparticles', 'timeFrame': 'Change from baseline at 14 days', 'description': 'Flow cytometric analysis using whole blood'}, {'measure': 'Plasma flavanol metabolite analysis', 'timeFrame': 'Change from baseline at 14 days', 'description': 'HPLC-MS assessment of metabolite profile and content of plasma'}, {'measure': 'Plasma Nitrite & Nitrate analysis', 'timeFrame': 'Change from baseline at 14 days', 'description': 'HPLC-based system with inbuilt colorimetric Griess reaction assay for the assessment of Nitrite \\& Nitrate in plasma'}, {'measure': 'Serum analysis of cardivascular-related blood marker(s) concentration', 'timeFrame': 'Change from baseline at 14 days', 'description': 'ILAB assessment of serum content of glucose, Triglycerides, total cholesterol, HDL-cholesterol, C-reactive protein and Non-esterified fatty acids'}, {'measure': 'Serum analysis of insulin', 'timeFrame': 'Change from baseline at 14 days', 'description': 'ELIZA kits for determination of insulin concentration in serum'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Flow-mediated dilatation (FMD)', 'Vascular function', 'cognitive function'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'A randomised, placebo-controlled, parallel human dietary intervention trial conducted in 33 healthy males to investigate the vascular and cognitive effects of bi-daily consumption of high-flavanol (epicatechin-rich) milk chocolate over a 2-week intervention period. Subjects visited the Hugh Sinclair Unit of Human Nutrition on 3 separate occasions; at the beginning, end and post-intervention.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Body Mass Index 18.5-27.5 kg/m2\n* Normal Blood pressure (\\< 150/90)\n* Non-smoker\n* Regular exercise routine\n* Signed consent form\n\nExclusion Criteria:\n\n* Haemoglobin (anaemia marker) \\< 125 g/l\n* Gamma GT (liver enzymes) \\> 80 IU/l\n* Total Cholesterol \\> 6.5 mmol/l\n* Suffered a myocardial infarction or stroke in the last 12 months\n* Suffers from any cardiovascular or metabolic disorders\n* Suffers from any blood-clotting disorder, and/or takes supporting medication\n* Any dietary restrictions or on a weight reducing diet\n* On any lipid-modifying or blood pressure lowering medication\n* Consuming any specific vitamin/ herbal supplements or fish oils'}, 'identificationModule': {'nctId': 'NCT02789761', 'briefTitle': 'The Vascular and Cognitive Effects of Chronic High-flavanol Intake in Healthy Males', 'organization': {'class': 'OTHER', 'fullName': 'University of Reading'}, 'officialTitle': 'The Vascular and Cognitive Effects of Chronic High-flavanol Intake in Healthy Males', 'orgStudyIdInfo': {'id': 'MCStudy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'High-flavanol milk chocolate', 'description': 'Bi-daily consumption of 12 g portion of a high-flavanol milk chocolate containing approximately 35 mg of (-)-epicatechin for 2-weeks (14 days)', 'interventionNames': ['Dietary Supplement: High-flavanol milk choocolate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Low-flavanol milk chocolate', 'description': 'Bi-daily consumption of 12 g portion of a low-flavanol milk chocolate containing approximately \\<1 mg of (-)-epicatechin for 2-weeks (14 days)', 'interventionNames': ['Dietary Supplement: Low-flavanol milk chocolate']}], 'interventions': [{'name': 'High-flavanol milk choocolate', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Epicatechin-rich milk chocolate'], 'armGroupLabels': ['High-flavanol milk chocolate']}, {'name': 'Low-flavanol milk chocolate', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Low-flavanol milk chocolate']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jeremy P Spencer, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Univerisity of Reading'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Reading', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Biochemistry', 'investigatorFullName': 'Jeremy Paul Edward Spencer', 'investigatorAffiliation': 'University of Reading'}}}}